ID

29862

Description

Study ID: 104864-201 Clinical Study ID: 104864/A201 Study Title: A Phase III, Open-Label, Multicenter, Randomized, Comparative Study of Topotecan, Ara-C and G-CSF (TAG) versus Idarubicin, Ara-C and G-CSF (IDAG) in MDS Patients with RAEB (High-Risk), RAEB-t or in Patients with AML from a Preceding Phase of MDS Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: hycamtin Study Indication: Myelodysplastic Syndrome https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

Link

https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

Keywords

Versions (1)
  1. 4/24/18 4/24/18 - Halim Ugurlu
Copyright Holder

GSK

Uploaded on

April 24, 2018

DOI

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License

Creative Commons BY-NC 3.0
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GSK Study ID 104864-201 Response Assessment Study Conclusion

English

Response Assessment / Study Conclusion

1 forms  
Identification Numbers
Description

Identification Numbers

Alias
UMLS CUI-1
C1300638
Center Number
Description

Center Number

Data type

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Patient Number
Description

Patient Number

Data type

text

Alias
UMLS CUI [1]
C1830427
Patient Initials
Description

Patient Initials

Data type

text

Alias
UMLS CUI [1]
C2986440
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Response Assessment at the end of the Course
Description

Response Assessment at the end of the Course

Alias
UMLS CUI-1
C0521982
UMLS CUI-2
C0220825
UMLS CUI-3
C0806020
UMLS CUI-4
C0750729
1- CR=Complete Response
Description

1- CR=Complete Response

Data type

boolean

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0205197
If Yes to Complete Response
Description

Mark one of the following

Data type

text

Alias
UMLS CUI [1,1]
C0521982
UMLS CUI [1,2]
C0205197
2- PR=Partial Response
Description

2- PR=Partial Response

Data type

boolean

Alias
UMLS CUI [1]
C1521726
15- HI=Hematologic Improvement
Description

15- HI=Hematologic Improvement

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0018943
UMLS CUI [1,3]
C1704632
UMLS CUI [1,4]
C2986411
3- SD=Stable Disease
Description

3- SD=Stable Disease

Data type

boolean

Alias
UMLS CUI [1]
C0677946
4- PD=Progressive Disease
Description

4- PD=Progressive Disease

Data type

boolean

Alias
UMLS CUI [1]
C1335499
If Yes to Progressive Disease
Description

Mark one of the following

Data type

text

Alias
UMLS CUI [1]
C1335499
8- ND= Complete Evaluation Not Done (Bone marrow evaluation and peripheral blood counts were not done) -> Complete the Study Conclusion section
Description

8- ND= Complete Evaluation Not Done

Data type

boolean

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C1272696
Response Assessment performed by
Description

Response Assessment performed by

Data type

text

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C0521982
Study Status
Description

Study Status

Alias
UMLS CUI-1
C2348568
Is the patient continuing in the study?
Description

Study Status

Data type

text

Alias
UMLS CUI [1]
C2348568
Best Overall Response Assessment
Description

Best Overall Response Assessment

Alias
UMLS CUI-1
C2986560
UMLS CUI-2
C1516048
Not Required
Description

Complete this section only if the patient discontinues at Course 1. Mark the box if not required.

Data type

boolean

Alias
UMLS CUI [1,1]
C1514873
UMLS CUI [1,2]
C1518422
Best Overall Response Assessment
Description

Best Overall Response Assessment

Data type

text

Alias
UMLS CUI [1,1]
C2986560
UMLS CUI [1,2]
C1516048
Date for blood counts return to normal or have stabilized
Description

Please enter the date when blood counts return to normal or have stabilized following the last course of treatment. Patient will be considered to have finished treatment and will enter the Post Treatment Follow-up phase

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0205307
UMLS CUI [1,3]
C0005768
UMLS CUI [1,4]
C0079107
UMLS CUI [1,5]
C0005771
Study Conclusion
Description

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008972
Did the patient complete the study as planned
Description

Complete the study

Data type

boolean

Alias
UMLS CUI [1]
C2348577
If 'No', mark the Primary cause of withdrawal
Description

If No to Complete the Study

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0085978
Date of Final Study Evaluation
Description

Date of Final Study Evaluation

Data type

date

Alias
UMLS CUI [1,1]
C0220825
UMLS CUI [1,2]
C0011008
Investigator`s Signature
Description

Investigator`s Signature

Alias
UMLS CUI-1
C2346576
Investigator`s Signature
Description

Investigator`s Signature

Data type

text

Alias
UMLS CUI [1]
C2346576
Date of Investigator`s Signature
Description

Date of Investigator`s Signature

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Similar models

Response Assessment / Study Conclusion

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Identification Numbers
C1300638 (UMLS CUI-1)
Center Number
Item
Center Number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Patient Number
Item
Patient Number
text
C1830427 (UMLS CUI [1])
Patient Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Response Assessment at the end of the Course
C0521982 (UMLS CUI-1)
C0220825 (UMLS CUI-2)
C0806020 (UMLS CUI-3)
C0750729 (UMLS CUI-4)
1- CR=Complete Response
Item
1- CR=Complete Response
boolean
C0521982 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Item
If Yes to Complete Response
text
C0521982 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
If Yes to Complete Response
Code List
If Yes to Complete Response
CL Item
Hematologic Response (8)
CL Item
Cytogenic Response (9)
CL Item
Hematologic and Cytogenic Response (10)
2- PR=Partial Response
Item
2- PR=Partial Response
boolean
C1521726 (UMLS CUI [1])
15- HI=Hematologic Improvement
Item
15- HI=Hematologic Improvement
boolean
C0012634 (UMLS CUI [1,1])
C0018943 (UMLS CUI [1,2])
C1704632 (UMLS CUI [1,3])
C2986411 (UMLS CUI [1,4])
3- SD=Stable Disease
Item
3- SD=Stable Disease
boolean
C0677946 (UMLS CUI [1])
4- PD=Progressive Disease
Item
4- PD=Progressive Disease
boolean
C1335499 (UMLS CUI [1])
Item
If Yes to Progressive Disease
text
C1335499 (UMLS CUI [1])
If Yes to Progressive Disease
Code List
If Yes to Progressive Disease
CL Item
By Bone Marrow Evaluation and Peripheral Blood Counts (5)
CL Item
By Bone Marrow Evaluation Only (6)
CL Item
By Peripheral Blood Counts Only (7)
8- ND= Complete Evaluation Not Done
Item
8- ND= Complete Evaluation Not Done (Bone marrow evaluation and peripheral blood counts were not done) -> Complete the Study Conclusion section
boolean
C0220825 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])
Response Assessment performed by
Item
Response Assessment performed by
text
C0220825 (UMLS CUI [1,1])
C0521982 (UMLS CUI [1,2])
Item Group
Study Status
C2348568 (UMLS CUI-1)
Item
Is the patient continuing in the study?
text
C2348568 (UMLS CUI [1])
Study Status
Code List
Is the patient continuing in the study?
CL Item
If 'No' Complete Best Overall Response Assessment, Study Conclusion and Investigator's Signature on the following page (No)
CL Item
If 'Yes' do NOT complete Best Overall Response Assessment or Study Conclusion on the following page. Only complete Investigator's Signature (Yes)
Item Group
Best Overall Response Assessment
C2986560 (UMLS CUI-1)
C1516048 (UMLS CUI-2)
Not Required
Item
Not Required
boolean
C1514873 (UMLS CUI [1,1])
C1518422 (UMLS CUI [1,2])
Item
Best Overall Response Assessment
text
C2986560 (UMLS CUI [1,1])
C1516048 (UMLS CUI [1,2])
Best Overall Response Assessment
Code List
Best Overall Response Assessment
CL Item
CR, Complete Response (1)
CL Item
PR, Partial Response (2)
CL Item
HI, Hematologic Improvement (15)
CL Item
SD, Stable Disease (3)
CL Item
PD, Progressive Disease (4)
CL Item
NE, Non-evaluable for Response (8)
Date for blood counts return to normal or have stabilized
Item
Date for blood counts return to normal or have stabilized
date
C0011008 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0005768 (UMLS CUI [1,3])
C0079107 (UMLS CUI [1,4])
C0005771 (UMLS CUI [1,5])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008972 (UMLS CUI-2)
Complete the study
Item
Did the patient complete the study as planned
boolean
C2348577 (UMLS CUI [1])
Item
If 'No', mark the Primary cause of withdrawal
text
C0422727 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
If No to Complete the Study
Code List
If 'No', mark the Primary cause of withdrawal
CL Item
Adverse experience (Complete AE From) (1)
CL Item
Insufficient therapeutic effect (2)
CL Item
Protocol Deviation (including non-compliance) (3)
CL Item
Lost to follow-up (4)
CL Item
Other-specify:.............................. (7)
Date of Final Study Evaluation
Item
Date of Final Study Evaluation
date
C0220825 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Investigator`s Signature
C2346576 (UMLS CUI-1)
Investigator`s Signature
Item
Investigator`s Signature
text
C2346576 (UMLS CUI [1])
Date of Investigator`s Signature
Item
Date of Investigator`s Signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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